Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Impact of Measures Taken by the Federal Institute for Drugs and Medical Devices (BfArM) Regarding the Naming of Medicinal Products from 2010 to 2013 ***

Anja-Simone Wiedemann (Abschlußjahr: 2015)

Summary
Language: English
The name of a medicinal product is part of every marketing authorisation and serves as important identification and differentiation parameter. Consequently, the name has an integral function in regard to drug therapy safety (AMTS). In parallel to the Sound- and Look-Alike measure of the AMTS action plans, initiated by the Federal Ministry of Health in 2008, the decision was made to work out a new guidance document regarding the naming issue.
In the following years both a new guidance document was published, and the administrative practice in regard to the naming of medicinal products was changed. The Federal Institute for Drugs and Medical Devises, in German, "Bundesinstitut für Arzneimittel und Medizinprodukte" (BfArM), was one of the key players in the German reorganisation of the administrative practice, which started in 2010 with the announcement of modifications to administrative practice in regard to name change procedures and found its peak in 2013 with the self-binding of the administrative body to the new German guideline of the BfArM and the Paul-Ehrlich-Institute in regard to naming of medicinal products, the so called "Leitlinie des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehrlich-Instituts zur Bezeichnung von Arzneimitteln" (Naming Guideline).
With the administrative practice change in 2010, the BfArM officially emphasized its competence to evaluate and to interfere with name change procedures, by announcing to further on issue official notes of change to the marketing authorisation notice. It was highlighted that the marketing of the new name without that official note would be seen as illegal action. The development and release of the Naming Guideline additionally communicated the stricter rules. According to the BfArM the Naming Guideline should be seen as working and decision making tool for CAs as well as for applicants. It became obvious, that BfArM not only wanted to contribute to the safety of medicinal products, but also wanted to prevent the use of medicinal product names as advertisement aid. The latter was especially highlighted by the BfArM’s position in regard to umbrella brand concepts.
The measures the BfArM took and the interpretation of the law it communicated, lead to controversial discussions, as not all stake holders could agree with BfArM’s position. Especially the stricter way of medicinal product name evaluation has been vehemently criticized.
The thesis analyzes how the administrative practice change between 2010 and 2013 has to be evaluated in regard to applicability and exertion of influence, from today’s point of view. Based on German and European legislation the controversial issues are explained and analysed. The analysis primarily uses court decisions as evaluation tool, since jurisdiction as independent regulatory body gave legal interpretation contributing to the clarification of the controversial issues. Additionally AMIS data and information given in specialised literature are included.    
pages 48; Annexes: 7, pages 31